(106 days)
The Diazyme EZ Vitamin D Assay is intended for use in clinical laboratories for the quantitative determination of 25hydroxyvitamin D (25-OH-D) in human serum and plasma on automated chemistry analyzers. Measurement of 25hydroxyvitamin D (25-OH-D) is for the assessment of vitamin D sufficiency. For in vitro diagnostic use only.
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The provided text is a 510(k) Premarket Notification letter from the FDA to Diazyme Laboratories for their Diazyme EZ Vitamin D Assay. This document is a regulatory approval letter for an in vitro diagnostic (IVD) device, specifically a chemical assay to measure Vitamin D levels.
The questions you've asked (1-9) are typical for the clinical validation of an AI/ML-based diagnostic device, especially those that process medical images. The information needed to answer these questions, such as "acceptance criteria" based on metrics like sensitivity, specificity, or AUC, "sample sizes for test sets," "number of experts," "adjudication methods," "MRMC studies," and "standalone performance," are not applicable or present in this document.
This document confirms the device's substantial equivalence to a predicate device and states its intended use, but it does not contain the detailed performance study results that would typically be required for an AI/ML diagnostic system. For an IVD assay like the Diazyme EZ Vitamin D Assay, acceptance criteria and performance data would typically be demonstrated through:
- Analytical Performance Studies: Accuracy (trueness/bias), precision (repeatability, reproducibility), linearity, analytical measuring range, limit of detection, limit of quantitation, interference, etc.
- Clinical Performance Studies: Correlation with a reference method, clinical utility, and potentially comparative studies with other assays.
Therefore, I cannot populate the table or answer questions 1-9 based on the provided text. The text is a regulatory approval letter, not a detailed clinical study report for an AI/ML device.
§ 862.1825 Vitamin D test system.
(a)
Identification. A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.(b)
Classification. Class II (special controls). Vitamin D test systems must comply with the following special controls:(1) Labeling in conformance with 21 CFR 809.10 and
(2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards.